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Although you can comment on any guidance at any time (see 21 CFR 10.115(g)(5)), to ensure that the FDA considers your comment on a draft guidance before it begins work on the final version of the guidance, submit either online or written comments on the draft guidance before the close date.
If unable to submit comments online, please mail written comments to:
Dockets Management
Food and Drug Administration
5630 Fishers Lane, Rm 1061
Rockville, MD 20852
All written comments should be identified with this document's docket number: FDA-2025-D-1757
- Docket Number:
- FDA-2025-D-1757
- Issued by:
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Guidance Issuing Office
Oncology Center of Excellence
This guidance is intended to assist sponsors in identifying an optimized dosage(s) (administered activity and schedule) for radiopharmaceutical therapies (RPTs) for oncology indications during clinical development and prior to submitting a marketing application for a new indication and usage.
This guidance should be considered along with the FDA guidance Optimizing the Dosage of Human Prescription Drugs and Biological Products for the Treatment of Oncologic Diseases (August 2024). Some of the recommendations outlined in that guidance may be applicable to RPTs; however, this guidance is more specific to RPTs.
This guidance does not address selection of the initial RPT administered activity in first-in-human trials nor does it address other aspects of the clinical development of RPTs, for example, use of dosimetry software, use of fixed administered activity dosing for a population versus dosing determined by personalized dosimetry, and theranostic co-development.
